Device product
25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
Z-0120-2017
Product summary
- Firm
- Synergetics Inc
- Event
- Event 74918
- Status
- Terminated
- Classification
- Class II
- Quantity
- 72 units
- Official record key
device-enforcement:Z-0120-2017
Official wording
Reason: Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Code information: Lot number M548370 (1 each or box of 6 each), exp 11/2018 Lot number M578150 (1 each or box of 6 each), exp 02/2019
Distribution pattern: Devices were distributed to KY, VA, TN, OH, IN, CA, NJ, NY, TX, SC, AL, MS, MI, and UT. Foreign distribution to the UK, France, Mexico, and India.
Derived failure modes
-
Unknown
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.